vedolizumab (Rx)

Brand and Other Names:Entyvio
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 300mg/vial (300mg/5mL after reconstituted)

Ulcerative Colitis

Indicated for adults with moderate-to-severe active ulcerative colitis

300 mg IV at weeks 0, 2, and 6, THEN

300 mg IV q8weeks

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Crohn Disease

Indicated for adults with moderate-to-severe active Crohn disease

300 mg IV at weeks 0, 2, and 6, THEN

300 mg IV q8weeks

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14

Dosage Modifications

Renal or hepatic impairment

  • Not studied

Dosing Considerations

Before initiating treatment, all patients should be brought up to date with all immunizations according to current immunization guidelines

Graft vs Host Disease (Orphan)

Orphan designations for prevention and treatment of graft versus host disease (GVHD)

Sponsor

  • Millennium Pharmaceuticals, Inc; 40 Landsdowne St; Cambridge, Massachusetts 02139

Safety and efficacy not established

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Interactions

Interaction Checker

and vedolizumab

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (21)

              • adalimumab

                vedolizumab and adalimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • adenovirus types 4 and 7 live, oral

                vedolizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • baricitinib

                baricitinib, vedolizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • BCG vaccine live

                vedolizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • certolizumab pegol

                vedolizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • etanercept

                vedolizumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • golimumab

                vedolizumab and golimumab both increase increasing elimination. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • infliximab

                vedolizumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • influenza virus vaccine quadrivalent, intranasal

                vedolizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • lenalidomide

                vedolizumab and lenalidomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • measles (rubeola) vaccine

                vedolizumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • measles mumps and rubella vaccine, live

                vedolizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • natalizumab

                vedolizumab, natalizumab. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration because of the potential for increased risk of PML and other infections.

              • rotavirus oral vaccine, live

                vedolizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • rubella vaccine

                vedolizumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • smallpox (vaccinia) vaccine, live

                vedolizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • thalidomide

                vedolizumab and thalidomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

              • typhoid vaccine live

                vedolizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • varicella virus vaccine live

                vedolizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • yellow fever vaccine

                vedolizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              • zoster vaccine live

                vedolizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

              Monitor Closely (10)

              • ifosfamide

                ifosfamide, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • lomustine

                lomustine and vedolizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

              • mechlorethamine

                mechlorethamine, vedolizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ofatumumab SC

                ofatumumab SC, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • oxaliplatin

                oxaliplatin and vedolizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

              • ozanimod

                ozanimod, vedolizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • ponesimod

                ponesimod and vedolizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • trastuzumab

                trastuzumab, vedolizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, vedolizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • zoster vaccine recombinant

                vedolizumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

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                Adverse Effects

                >10%

                Nasopharyngitis (13%)

                Headache (12%)

                Arthralgia (12%)

                1-10%

                Nausea (9%)

                Pyrexia (9%)

                Upper respiratory tract infection (7%)

                Fatigue (6%)

                Cough (5%)

                Bronchitis (4%)

                Influenza (4%)

                Back pain (4%)

                Rash (3%)

                Pruritus (3%)

                Sinusitis (3%)

                Oropharyngeal pain (3%)

                Pain in extremities (3%)

                <1%

                Infections (0.85% per patient-year)

                Infusion-related hypersensitivity (0.07%)

                Serious infections (0.06% per patient-year)

                Postmarketing Reports

                Anaphylaxis

                Acute pancreatitis

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                Warnings

                Contraindications

                Hypersensitivity

                Cautions

                Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased BP and HR observed

                Increased risk for developing infections; serious infections have also been reported, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis

                Elevated liver transaminases and/or bilirubin reported; discontinue if jaundice occurs or other evidence of liver injury (eg, fatigue, anorexia, right upper abdominal discomfort); the combination of elevated transaminase and bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for liver transplantation

                Infusion-related reactions and hypersensitivity reactions

                • Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate
                • May occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours postinfusion
                • If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue immediately and initiate appropriate treatment

                Progressive multifocal leukoencephalopathy (PML)

                • Another integrin receptor antagonist (natalizumab) has been associated with PML, a rare and often fatal opportunistic infection of the CNS
                • Vedolizumab inhibits α4β7 integrin; whereas, natalizumab inhibits both α4β7 (gut integrin) and α4β1 (CNS integrin)
                • In vedolizumab clinical trials, monitor for PML with frequent and regular screenings and evaluations of any new, unexplained neurological symptoms, as necessary
                • While zero cases of PML were identified among patients with at least 24 months of vedolizumab exposure, a risk of PML cannot be ruled out
                • No claims of comparative safety to other integrin receptor antagonists can be made based on these data

                Drug interaction overview

                • Immunizations for each patient should be current before initiating treatment; patients may receive non-live vaccines (eg, influenza vaccine injection) and may receive live vaccines if the benefits outweigh the risks; there are no data on secondary transmission of infection by live vaccines in patients receiving vedolizumab
                • Owing to the potential for increased risk of PML and other infections, avoid use with natalizumab
                • Owing to the potential for increased risk of infections, avoid use with TNF blockers
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                Pregnancy & Lactation

                Pregnancy

                Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

                Pregnancy registry

                • Monitors pregnancy outcomes in women exposed to during pregnancyInformation about the registry can be obtained by calling 1-877-TAKEDA7 (1-877-825-3327)

                Disease-associated maternal and embryo/fetal risk

                • Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity
                • Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth

                Fetal/Neonatal adverse reactions

                • Administered during pregnancy could affect immune responses in the in utero exposed newborn and infant
                • Clinical significance of low levels of vedolizumab in utero-exposed infants is unknown
                • Safety of administering live or live-attenuated vaccines in exposed infants is unknown

                Lactation

                Available published literature suggests presence of vedolizumab in human milk

                The mean calculated daily infant dosage was 0.02 mg/kg/day orally; systemic exposure in breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract

                There are no data on effects of vedolizumab on breastfed infant, or effects on milk production

                Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant humanized monoclonal antibody that binds specifically to α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue

                Does not bind to or inhibit function of α4β1 and αEβ7 integrins and does not antagonize α4 integrins interaction with vascular cell adhesion molecule-1 (VCAM-1)

                Elicits no activity against α4β1 integrin, and therefore there has no effect on CNS inflammation

                Absorption

                Trough serum concentration (ulcerative colitis): 26.3 mcg/mL (Week 6); 11.2 mcg/mL (Week 46)

                Trough serum concentration (Crohns disease): 27.4 mcg/mL (Week 6); 13 mcg/mL (Week 46)

                Distribution

                Vd: 5 L

                Elimination

                Half-life: 25 days

                Clearance (linear): 0.157 L/day

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                Administration

                IV Compatibilities

                0.9% NaCl

                Lactated Ringer

                IV Preparation

                Reconstitution

                • Reconstitute vial with 4.8 mL sterile water for injection
                • Direct stream of sterile water for injection to the glass wall of the vial to avoid excessive foaming
                • Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder; do NOT vigorously shake or invert
                • Allow solution to sit for up to 20 minutes at room temperature to allow for reconstitution and for any foam to settle; swirl and inspect for dissolution during this time
                • If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution; do NOT use the vial if the drug product is not dissolved within 30 minutes
                • Visually inspect the reconstituted solution for particulate matter and discoloration before administration; solution should be clear or opalescent, colorless to light brownish-yellow and free of visible particulates
                • Do not administer reconstituted solution showing uncharacteristic color or containing particulates
                • Before withdrawing the reconstituted solution from the vial, gently invert vial 3 times
                • Withdraw 5 mL (300 mg) of reconstituted solution to 250 mL 0.9% NaCl and gently mix the infusion bag any remaining portion of the reconstituted solution in the vial; discard any unused solution remaining in the vial

                IV Administration

                Infuse over 30 min

                Do not administer as an IV push or bolus

                After infusion is complete, flush with 30 mL of sterile 0.9% NaCl or sterile Lactated Ringer

                Storage

                Unopened vials

                • Refrigerate unopened vials at 2-8°C (36-46ºF)
                • Retain in original package to protect from light

                Diluted infusion solution

                • If necessary, may be stored for up to 4 hr at 2-8°C (36- 46ºF)
                • Do not freeze
                • Discard any unused portion of the infusion solution
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                Images

                No images available for this drug.
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                Patient Handout

                Patient Education
                vedolizumab intravenous

                VEDOLIZUMAB - INJECTION

                (VE-doe-LIZ-ue-mab)

                COMMON BRAND NAME(S): Entyvio

                USES: This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.

                HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using vedolizumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist. Discuss the risks and benefits of vedolizumab treatment.Before starting treatment with vedolizumab, you should be up to date with all your vaccinations. Ask your doctor if you need to receive any vaccines before starting vedolizumab.This medication is given by injection into a vein by a health care professional. It should be injected slowly over 30 minutes. After the first dose, you will usually receive the next two doses 2 weeks and 6 weeks later. After the third dose, this medication is given as directed by your doctor, usually every 8 weeks.Serious allergic reactions can happen during or even several hours after your treatment. Careful monitoring by your doctor may decrease your risk. If you have a serious reaction, your treatment will be temporarily stopped. Get medical help right away if you have shortness of breath, fast heartbeat, flushing, or rash/itching.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: See also How to Use section.Nausea, headache, flu/common cold symptoms, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mouth/throat pain, pain in your arms/legs, symptoms of liver damage (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using vedolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: symptoms of infection (such as fever, chills, sore throat, cough, runny nose), current/past/returning infections (such as tuberculosis), cancer.Vedolizumab can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Tell your doctor if you have had any recent immunizations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, TNF blockers such as adalimumab/infliximab).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Laboratory and/or medical tests (such as endoscopy, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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